A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: erlotinib [Tarceva] (Drug); fusidic acid [Verutex] (Drug); erythromycin [Eritex] (Drug); Fisiogel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Official title: A Randomized, Open Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Participants Who Develop Skin Rash

Percentage of Participants With Skin Rash Stratified by Severity Grade

Secondary outcome:

Time to Appearance of Skin Rash

Percentage of Participants With Erythema

Percentage of Participants With Pruritus

Percentage of Participants With Pain

Percentage of Participants With Erythema Stratified by Severity Grade

Percentage of Participants With Pruritus Stratified by Severity Grade

Percentage of Participants With Pain Stratified by Severity Grade

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV);

- eligible to start treatment with Tarceva, or receiving Tarceva for <=5 days.

Exclusion Criteria:

- presence of skin rash or other signs of skin toxicity;

- treatment with any systemic or intranasal antibiotic within 7 days before

randomization;

- treatment with other topical formulation within 14 days before randomization;

- other anticancer therapy in addition to Tarceva.

Salvador, BA 40110-150, Brazil

Salvador, BA 40170-110, Brazil

Salvador, BA 41950-610, Brazil

Fortaleza, CE 60125-151, Brazil

Fortaleza, CE 60190-800, Brazil

Taguatinga, DF 72115-700, Brazil

Goiania, GO 74140-050, Brazil

Belo Horizonte, MG 30150-281, Brazil

Belo horizonte, MG 30150-321, Brazil

Divinopolis, MG 35500-222, Brazil

Recife, PE 50070-170, Brazil

Curitiba, PR 80010030, Brazil

Curitiba, PR 80810-050, Brazil

Rio De Janeiro, RJ 22290-160, Brazil

Rio de Janeiro, RJ 22260-020, Brazil

Natal, RN 59040150, Brazil

Ijui, RS 98700-000, Brazil

Porto Alegre, RS 90430-090, Brazil

Itajai, SC 88301-220, Brazil

Ribeirao Preto, SP 14025-270, Brazil

Sao Paulo, SP 01221-020, Brazil

Sao Paulo, SP 01308-000, Brazil

Sao Paulo, SP 01323-000, Brazil

Sao Paulo, SP 01406100, Brazil

Sao Paulo, SP 04039-901, Brazil

Sao Paulo, SP 05652-000, Brazil

Starting date: April 2009
Last updated: January 9, 2015